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NCT06225544: LHOxH
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
Phase 2 trial testing Lumasiran in Haemodialysis in 50 participants. Currently enrolling.
30 January 2025
Quick facts
| Lead sponsor | Charite University, Berlin, Germany |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 14 April 2024 |
| Primary completion | 30 January 2025 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Lumasiran (LUMASIRAN) — full drug profile →
- 0.9% Sodium Chloride (placebo)
Conditions studied
- Haemodialysis — all drugs for Haemodialysis →
- Chronic Kidney Disease Requiring Chronic Dialysis — all drugs for Chronic Kidney Disease Requiring Chronic Dialysis →
- Cardiovascular Disease — all drugs for Cardiovascular Disease →
- Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
Sponsor
Charite University, Berlin, Germany
Who can join
Adults 18 to 80, any sex, with Haemodialysis or Chronic Kidney Disease Requiring Chronic Dialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. This study will investigate if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis. The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study. At the start of the study all the participants will have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8 -
Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f
Verify or expand the search:
- PubMed search for NCT06225544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lumasiran
Trials testing the same drug.
- NCT05161936 — A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate · Phase 2 · terminated
- NCT04152200 — A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 · Phase 3 · completed
- NCT03905694 — A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1 · Phase 3 · completed
- NCT03681184 — A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 · Phase 3 · completed
- NCT03350451 — An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1 · Phase 2 · completed
Other recruiting trials for Haemodialysis
Currently open trials in the same condition.
- NCT07427264 — The Effect of a Mixed-type Intradialytic Exercise Training Program on Body Composition, Functional Capacity, and Muscle · NA · active not recruiting
- NCT06641765 — Continuous Glucose Monitoring in Dialysis Patients With Diabetes · NA · active not recruiting
- NCT04842591 — Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation · active not recruiting
Other Charite University, Berlin, Germany trials
Trials by the same sponsor.
- NCT07486167 — Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congeni · Phase 1, PHASE2 · not yet recruiting
- NCT07476729 — International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) · Phase 3 · not yet recruiting
- NCT07503054 — Ovarian Cancer Screening and AI · NA · not yet recruiting
- NCT07529197 — Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS · recruiting
- NCT07388693 — Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06225544 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Charite University, Berlin, Germany
- Last refreshed: 21 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06225544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing